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Opioid-free Total Hip Arthroplasty

Primary Purpose

Hip Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exclusion of opioid analgesics
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of all ages with end-stage primary hip osteoarthritis.

Exclusion Criteria:

  • Patients with creatinine clearance between 30 and 60 mL/min
  • Use of any opioid analgesics in the 6 months preceding surgery
  • Revision total hip arthroplasty
  • Patients with liver insufficiency
  • Patients on chronic anticoagulation
  • Workers compensation patients
  • Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any reason (e.g. allergies)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard multimodal analgesic pathway with opioids

    Modified multimodal analgesic pathway without opioids

    Arm Description

    This is the control group, who will receive the current standard multimodal analgesic regimen, which includes opioids following total hip arthroplasty at Johns Hopkins Bayview Hospital. The current standard multimodal analgesic regimen utilizes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Opioid (fentanyl) & Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: 0.25 % bupivacaine with epinephrine and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Oxycodone 5-10 mg PO, IV opioids (Morphine, hydromorphone), Acetaminophen 1000 mg PO q6hr

    This is the experimental group, who will receive a modified multimodal analgesic regimen, which excludes the use of any opioids. The modified multimodal analgesic regimen utilizes the following medications: includes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: Liposomal bupivacaine, 0.25 % bupivacaine with epinephrine, Betamethasone sodium phosphate, betamethasone acetate and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Ketamine IV, Ketorolac 15 mg PO, Acetaminophen 1000 mg PO q6hr

    Outcomes

    Primary Outcome Measures

    Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores
    Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt

    Secondary Outcome Measures

    Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS)
    A patient-reported measure that assesses components such as assesses patient pain, satisfaction including stiffness and range of motion, activity limitations-daily living, sports and recreation function, and quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.
    Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale
    The UCLA scale is a patient-reported measure ranging from 1 to 10. Patients indicate their most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports."

    Full Information

    First Posted
    May 19, 2020
    Last Updated
    September 19, 2022
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04421196
    Brief Title
    Opioid-free Total Hip Arthroplasty
    Official Title
    Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Currently does not have active IRB status.
    Study Start Date
    September 15, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary objective of investigators' proposed study is to demonstrate that the following two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS) scores up to 3 months post-operatively: one that is administered a modified multimodal analgesic pathway without opioids and the other administered the current standard multimodal analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The secondary objective is to demonstrate that these cohorts will also have equivalent functional outcomes as determined by both objective measures (such as hip range of motion) and patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard multimodal analgesic pathway with opioids
    Arm Type
    No Intervention
    Arm Description
    This is the control group, who will receive the current standard multimodal analgesic regimen, which includes opioids following total hip arthroplasty at Johns Hopkins Bayview Hospital. The current standard multimodal analgesic regimen utilizes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Opioid (fentanyl) & Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: 0.25 % bupivacaine with epinephrine and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Oxycodone 5-10 mg PO, IV opioids (Morphine, hydromorphone), Acetaminophen 1000 mg PO q6hr
    Arm Title
    Modified multimodal analgesic pathway without opioids
    Arm Type
    Experimental
    Arm Description
    This is the experimental group, who will receive a modified multimodal analgesic regimen, which excludes the use of any opioids. The modified multimodal analgesic regimen utilizes the following medications: includes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: Liposomal bupivacaine, 0.25 % bupivacaine with epinephrine, Betamethasone sodium phosphate, betamethasone acetate and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Ketamine IV, Ketorolac 15 mg PO, Acetaminophen 1000 mg PO q6hr
    Intervention Type
    Other
    Intervention Name(s)
    Exclusion of opioid analgesics
    Intervention Description
    The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.
    Primary Outcome Measure Information:
    Title
    Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores
    Description
    Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt
    Time Frame
    From immediate post-operative period to 3 months post-operatively
    Secondary Outcome Measure Information:
    Title
    Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS)
    Description
    A patient-reported measure that assesses components such as assesses patient pain, satisfaction including stiffness and range of motion, activity limitations-daily living, sports and recreation function, and quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.
    Time Frame
    From pre-operative clinic visit to immediate post-operative period, then to 3 months post-operatively
    Title
    Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale
    Description
    The UCLA scale is a patient-reported measure ranging from 1 to 10. Patients indicate their most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports."
    Time Frame
    From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients of all ages with end-stage primary hip osteoarthritis. Exclusion Criteria: Patients with creatinine clearance between 30 and 60 mL/min Use of any opioid analgesics in the 6 months preceding surgery Revision total hip arthroplasty Patients with liver insufficiency Patients on chronic anticoagulation Workers compensation patients Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any reason (e.g. allergies)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julius Oni, M.D.
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29570781
    Citation
    Madras BK. The President's Commission on Combating Drug Addiction and the Opioid Crisis: Origins and Recommendations. Clin Pharmacol Ther. 2018 Jun;103(6):943-945. doi: 10.1002/cpt.1050. Epub 2018 Mar 23.
    Results Reference
    background
    PubMed Identifier
    31327956
    Citation
    Rodriguez-Merchan EC, Vaquero-Picado A, Ruiz-Perez JS. Correction to: Opioid-Free Total Knee Arthroplasty? Local Infiltration Analgesia Plus Multimodal Blood-Loss Prevention Make it Possible. HSS J. 2019 Jul;15(2):209. doi: 10.1007/s11420-019-09679-x. Epub 2019 Apr 1.
    Results Reference
    background
    PubMed Identifier
    31072655
    Citation
    Leas DP, Connor PM, Schiffern SC, D'Alessandro DF, Roberts KM, Hamid N. Opioid-free shoulder arthroplasty: a prospective study of a novel clinical care pathway. J Shoulder Elbow Surg. 2019 Sep;28(9):1716-1722. doi: 10.1016/j.jse.2019.01.013. Epub 2019 May 6.
    Results Reference
    background
    PubMed Identifier
    28059869
    Citation
    Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
    Results Reference
    background
    PubMed Identifier
    10861154
    Citation
    Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.
    Results Reference
    background
    PubMed Identifier
    18028577
    Citation
    Becchi C, Al Malyan M, Coppini R, Campolo M, Magherini M, Boncinelli S. Opioid-free analgesia by continuous psoas compartment block after total hip arthroplasty. A randomized study. Eur J Anaesthesiol. 2008 May;25(5):418-23. doi: 10.1017/S026502150700302X. Epub 2007 Nov 21.
    Results Reference
    background

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    Opioid-free Total Hip Arthroplasty

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